A new approach to real-world evidence

September 8, 2017 – The Robert J. Margolis, MD, Center for Health Policy at Duke University has issued a white paper in advance of its upcoming one-day workshop on the use of real-world evidence.

Adrian Hernandez

As the demand for more use of real-evidence (RWE) grows, so does the need for a more nuanced and considered approach to it. That is the conclusion of a white paper issued by the Robert J. Margolis, MD, Center for Health Policy at Duke University in advance of its Sept. 13 workshop on real-world evidence.

The DCRI’s Adrian Hernandez, MD, MHS, is among the white paper’s authors.

In recent years the amount of patient data collected outside of clinical trials has become more plentiful and, with the advent of electronic health records, more easily accessible. Researchers and clinicians have recognized the potential uses of this information, but questions remain about how to best use it.

“Here, we advance the idea that RWE is the output from the combination of a variety of different RWD sources and methods for evidence development, and that the resultant applicability of RWE will necessarily vary across regulatory contexts of use,” the authors write. “Appropriately matching data and methods to potential uses will take time and input from all stakeholders involved in the development and use of medical products, but progress can be made if thoughtful and transparent collaborations can improve underlying challenges in data collection, study design, and shared infrastructure.”

The complete paper can be downloaded here.